Systems and methods employing remote data gathering and monitoring for diagnosing, staging, and treatment of parkinsons disease, movement and neurological disorders, and chronic pain

ABSTRACT

This disclosure relates to early diagnosis and assessment tools for Parkinson&#39;s disease, movement disorder, neurological disease, and/or chronic pain, designed to drive innovation and to accelerate best Parkinson&#39;s disease, movement disorders, neurological disease, and chronic pain research. The present disclosure facilitates improved access to Parkinson&#39;s disease, movement disorders, neurological disease, and chronic pain patients along with innovative data capture methods that are designed to leading to improved therapies and assisting in finding a cure for Parkinson&#39;s disease, movement disorders, neurological diseases, and/or chronic pain. In addition the present disclosure is broadly applicable as a diagnosis and assessment tool to all movement disorders and many neurological diseases and/or chronic pain.

RELATED U.S. APPLICATION DATA

This application claims the benefit of U.S. Provisional Patent Application No. 61/086,136 filed on Aug. 4, 2008, which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates to early diagnosis, staging, assessment and treatment tools for Parkinson's disease (PD), movement disorders, neurological diseases, and/or chronic pain, designed to drive innovation and to best accelerate research into Parkinson's disease, movement disorders, neurological diseases, and/or chronic pain. The present disclosure facilitates improved access to patients suffering from such disorders along with innovative data capture methods designed to lead to improved therapies and assist in finding a cure for these disorders. The present disclosure is broadly applicable as a diagnosis and assessment tool for Parkinson's disease, movement disorders and many neurological diseases and chronic pain.

BACKGROUND

Parkinson's disease (PD) is a chronic and progressive degenerative disease of the brain that impairs motor control, speech, and other functions. The disease is named after English physician James Parkinson, who gave a detailed description of it in an 1817 work titled, “An Essay on the Shaking Palsy”.

Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, resting tremor (typically at about 5 Hz), slowing of movement (bradykinesia) and, in extreme cases, nearly complete loss of movement (akinesia). Secondary symptoms may include high level cognitive dysfunction, subtle language problems, and depression.

In contrast to many other neurological disorders, the nature of the brain degeneration that produces Parkinson's disease has been well understood for decades. The symptoms are caused by loss of nerve cells that secrete dopamine in a tiny midbrain area called the substantia nigra. These nerve cells, for reasons that are not fully understood, are especially vulnerable to damage of various sorts, including drugs, disease, and head trauma. The term Parkinsonism is used for any process that destroys large numbers of these cells and thereby causes the same characteristic symptoms. Parkinson's disease, or more fully, idiopathic Parkinson's disease, is diagnosed when no specific physical cause for the loss of dopamine cells can be identified. This is the most common situation.

The term Parkinsonism is used for symptoms of tremor, stiffness, and slowing of movement caused by loss of dopamine cells in the substantia nigra. “Parkinson's disease” is the synonym of “primary Parkinsonism”, i.e. isolated Parkinsonism due to a neurodegenerative process without any secondary systemic cause. In some cases, it would be inaccurate to say that the cause is “unknown” because a small proportion is caused by identifiable genetic mutations. It is possible for a patient to be initially diagnosed with Parkinson's disease but then to develop additional features requiring revision of the diagnosis.

There are other disorders called Parkinson-plus diseases. These include: multiple system atrophy (MSA), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), and dementia with Lewy bodies (DLB). Lewy bodies are abnormal aggregates of protein that develop inside nerve cells. Most idiopathic Parkinson's disease patients also have Lewy bodies in their brain tissue, but the distribution is denser and more widespread in DLB. Even so, the relationship between Parkinson's disease, Parkinson's disease with dementia, and dementia with Lewy bodies (DLB) might be most accurately conceptualized as a spectrum, with a discrete area of overlap between each of the three disorders. The natural history and role of Lewy bodies is little understood.

These Parkinson-plus diseases may progress more quickly than typical idiopathic Parkinson disease. If cognitive dysfunction occurs before or very early in the course of the movement disorder then DLB may be suspected. Early postural instability with minimal tremor especially in the context of ophthalmoparesis should suggest PSP. Early autonomic dysfunction including erectile dysfunction and syncope may suggest MSA. The presence of extreme asymmetry with patchy cortical cognitive defects such as dysphasia and apraxias especially with “alien limb” phenomena should suggest CBD.

The usual anti-Parkinson's medications are typically either less effective or not effective at all in controlling symptoms; patients may be exquisitely sensitive to neuroleptic medications like haloperidol. Additionally, the cholinesterase inhibiting medications have shown preliminary efficacy in treating the cognitive, psychiatric, and behavioral aspects of the disease, so correct differential diagnosis is important.

Essential tremor may be mistaken for Parkinson's disease but lacks all other features besides tremor, and has particular characteristics distinguishing it from Parkinson's, such as improvement with beta blockers and alcoholic beverages (see http://en.wikipedia.org/wiki/Parkinson's_disease—cite_note—Jankovic2008-0). Wilson's disease (hereditary copper accumulation) may present with Parkinsonian features; young patients presenting with Parkinsonism or any other movement disorder are frequently screened for this rare condition, because it may respond to medical treatment. Typical tests are liver function, slit lamp examination for Kayser-Fleischer rings, and serum ceruloplasmin levels.

Parkinson's disease affects movement (motor symptoms). Other typical symptoms include disorders of mood, behavior, thinking, and sensation (non-motor symptoms). Patients' individual symptoms may be quite dissimilar and progression of the disease is also distinctly individual.

The cardinal symptoms of Parkinson's disease are:

-   -   Tremor: normally 4-6 Hz tremor, maximal when the limb is at         rest, and decreased with voluntary movement. It is typically         unilateral at onset. This is the most apparent and well-known         symptom though an estimated 30% of patients have little         perceptible tremor; these are classified as akinetic-rigid.     -   Rigidity: stiffness; increased muscle tone. In combination with         a resting tremor, this produces a ratchety, “cogwheel” rigidity         when the limb is passively moved.     -   Akinesia/bradykinesia: absence of movement and slowness,         respectively. Rapid, repetitive movements produce a dysrhythmic         and decremental loss of amplitude.     -   Postural instability: failure of postural reflexes, which leads         to impaired balance and falls.

Other motor symptoms include gait and posture disturbances:

-   -   Shuffling: gait is characterized by short steps with feet barely         leaving the ground, producing an audible shuffling noise. Small         obstacles tend to cause the patient to trip.     -   Decreased arm-swing.     -   Turning “en bloc”: rather than the usual twisting of the neck         and trunk and pivoting on the toes, Parkinson's disease patients         keep their neck and trunk rigid, requiring multiple small steps         to accomplish a turn.     -   Stooped, forward-flexed posture: In severe forms, the head and         upper shoulders may be bent at a right angle relative to the         trunk (camptocormia).     -   Festination: a combination of stooped posture, imbalance, and         short steps. It leads to a gait that gets progressively faster         and faster, often ending in a fall.     -   Gait freezing: “freezing” is a manifestation of akinesia (an         inability to move). Gait freezing is characterized by an         inability to move the feet which may worsen in tight, cluttered         spaces or when attempting to initiate gait.     -   Dystonia (in about 20% of cases): abnormal, sustained, painful         twisting muscle contractions, often affecting the foot and ankle         (mainly toe flexion and foot inversion), which often interferes         with gait.

Speech and swallowing disturbances:

-   -   Hypophonia: soft speech. Speech quality tends to be soft,         hoarse, and monotonous. Some people with Parkinson's disease         claim that their tongue is “heavy” or have cluttered speech.     -   Monotonic speech.     -   Festinating speech: excessively rapid, soft, poorly-intelligible         speech.     -   Drooling: most likely caused by a weak, infrequent swallow and         stooped posture.     -   Dysphagia: impaired ability to swallow; may lead to aspiration         pneumonia.

Other motor symptoms:

-   -   Fatigue (up to 50% of cases).     -   Masked faces (a mask-like face also known as hypomimia), with         infrequent blinking.     -   Difficulty rolling in bed or rising from a seated position.     -   Micrographia (small cramped handwriting).     -   Impaired fine motor dexterity and motor coordination.     -   Impaired gross motor coordination.     -   Akathisia: the inability to sit still.

Parkinson's disease causes cognitive and mood disturbances, being in many cases related. Estimated prevalence rates of depression vary widely according to the population sampled and methodology used. Reviews of depression estimate its occurrence in anywhere from 20-80% of cases. Estimates from community samples tend to find lower rates than from specialist centres. Most studies use self-report questionnaires such as the Beck Depression Inventory, which may overinflate scores due to physical symptoms. Studies using diagnostic interviews by trained psychiatrists also report lower rates of depression. More generally, there is an increased risk for any individual with depression to develop Parkinson's disease at a later date. Seventy percent of individuals with Parkinson's disease diagnosed with pre-existing depression go on to develop anxiety. Ninety percent of Parkinson's disease patients with pre-existing anxiety subsequently develop depression, apathy or abulia.

Cognitive disturbances include:

-   -   Slowed reaction time: both voluntary and involuntary motor         responses are significantly slowed.     -   Executive dysfunction, characterized by difficulties in:         differential allocation of attention, impulse control, set         shifting, prioritizing, evaluating the salience of ambient data,         interpreting social cues, and subjective time awareness. This         complex is present to some degree in most Parkinson's patients;         it may progress to:         -   Dementia: a later development in approximately 20-40% of all             patients, typically starting with slowing of thought and             progressing to difficulties with abstract thought, memory,             and behavioral regulation. Hallucinations, delusions and             paranoia may develop.         -   Short term memory loss: procedural memory is more impaired             than declarative memory. Prompting elicits improved recall         -   Non-motor causes of speech/language disturbance in both             expressive and receptive language: these include decreased             verbal fluency and cognitive disturbance especially related             to comprehension of emotional content of speech and of             facial expression.         -   Difficulty deceiving others that links to prefrontal             hypometabolism.         -   Medication effects: some of the above cognitive disturbances             are improved by dopaminergic medications, while others are             actually worsened.

Movement disorders are neurological conditions that affect the speed, fluency, quality, and ease of movement. Abnormal fluency or speed of movement (dyskinesia) may involve excessive or involuntary movement (hyperkinesia) or slowed or absent voluntary movement (hypokinesia).

Movement disorders include the following conditions:

-   -   Ataxia (lack of coordination, often producing jerky movements)     -   Dystonia (causes involuntary movement and prolonged muscle         contraction)     -   Huntington's disease (also called chronic progressive chorea)     -   Multiple system atrophies (e.g., Shy-Drager syndrome)     -   Myoclonus (rapid, brief, irregular movement)     -   Parkinson's disease     -   Progressive supranuclear palsy (rare disorder that affects         purposeful movement)     -   Restless leg syndrome (RSD) and periodic limb movement disorders         (PLMD)     -   Tics (involuntary muscle contractions)     -   Tourette's syndrome     -   Tremor (e.g., essential tremor, resting tremor)     -   Wilson disease (inherited disorder that causes neurological and         psychiatric symptoms and liver disease).

Common dystonias include spasmodic torticollis, which affects muscles of the head, face, and neck; and blepharospasm, which causes involuntary closing of the eyelids.

Tourette's syndrome is an inherited disorder characterized by multiple motor and vocal tics (repeated muscle contractions). Symptoms of Tourette's syndrome usually develop during childhood or early adolescence. Patients with the disorder often develop behavioral problems such as hyperactivity, inattention, impulsivity, obsessions, and compulsions. In most cases, symptoms vary in frequency and in severity.

Tics are involuntary muscle contractions that interrupt normal activities. They often are preceded by a strong sensation or urge that is temporarily relieved following the muscle contraction. Examples of common tics include the following: blinking, clearing the throat, facial twitching, grunting, shrugging the shoulders, and sighing.

Movement disorders occur as a result of damage or disease in a region located at the base of the brain (basal ganglia). The basal ganglia are comprised of clusters of nerve cells (neurons) that send and receive electrical signals and are responsible for involuntary movement. Movement disorders may result from at least one of the following: age-related changes, environmental toxins, genetic disorders (e.g., Huntington's disease, Wilson disease), medications (e.g., antipsychotic drugs), metabolic disorders (e.g., hyperthyroidism), Parkinson's disease, and stroke.

Neurologic Diseases are disorders of the brain, spinal cord and nerves throughout the body. Together they control all the workings of the body. When something goes wrong with a part of the nervous system, an individual may have trouble moving, speaking, swallowing, breathing or learning. The individual may also have problems with memory, senses or mood.

Currently there are more than 600 neurologic diseases. Thus, neurological disorders are disorders that can affect the central nervous system (brain and spinal cord), the peripheral nervous system, or the autonomic nervous system. Major conditions include:

-   -   behavioral/cognitive syndromes     -   headache disorders such as migraine, cluster headache and         tension headache     -   epilepsy     -   traumatic brain injury     -   neurodegenerative disorders, including Alzheimer's disease,         Parkinson's disease, Huntington's disease, and amyotrophic         lateral sclerosis (Lou Gehrig's disease)     -   cerebrovascular disease, such as transient ischemic attack and         stroke     -   sleep disorders     -   cerebral palsy     -   infections of the brain (encephalitis), brain meninges         (meningitis), spinal cord (myelitis)     -   infections of the peripheral nervous system     -   neoplasms: tumors of the brain and its meninges (brain tumors);         spinal cord tumors, tumors of the peripheral nerves (neuroma)     -   movement disorders, such as Parkinson's disease, Huntington's         disease, hemiballismus, tic disorder, and Tourette's syndrome     -   demyelinating diseases of the central nervous system, such as         multiple sclerosis, and of the peripheral nervous system, such         as Guillain-Barré syndrome and chronic inflammatory         demyelinating polyneuropathy (CIDP)     -   spinal cord disorders: tumors, infections, trauma, malformations         (e.g., myelocele, meningomyelocele, tethered cord)     -   disorders of peripheral nerves, muscle (myopathy) and         neuromuscular junctions     -   exciting injuries to the brain, spinal cord and peripheral         nerves     -   altered mental higher status, encephalopathy, stupor and coma     -   speech and language disorders; functional symptoms, having no         apparent physiological cause; and     -   paraneoplastic neurological syndromes.

Chronic Pain Overview:

While acute pain is a normal sensation triggered in the nervous system to alert an individual to possible injury and the need to take care of the situation or issue, chronic pain is different. Chronic pain persists. Pain signals keep firing in the nervous system for weeks, months, even years. There may have been an initial mishap, e.g.: sprained back, serious infection, or there may be an ongoing cause of pain, e.g.: arthritis, cancer, ear infection, but some people suffer chronic pain in the absence of any past injury or evidence of body damage.

Many chronic pain conditions affect older adults. Common chronic pain complaints include headache, low back pain, cancer pain, arthritis pain, neurogenic pain (pain resulting from damage to the peripheral nerves or to the central nervous system itself), psychogenic pain (pain not due to past disease or injury or any visible sign of damage inside or outside the nervous system).

Medications, acupuncture, local electrical stimulation, and brain stimulation, as well as surgery, are some treatments for chronic pain. Some physicians use placebos, which in some cases has resulted in a lessening or elimination of pain. Psychotherapy, relaxation and medication therapies, biofeedback, and behavior modification may also be employed to treat chronic pain. Many people with chronic pain may be helped if they understand the causes of pain and the many and varied steps that can be taken to undo what chronic pain has instantiated.

SUMMARY

This disclosure is directed to systems and methods, including computer-implemented systems and methods, to facilitate one or more of the following: diagnosis of disease; baseline and progression of disease staging; data gathering (e.g., biochemical, physical, neurological, and cognitive data gathering), including remote data gathering; monitoring, including remote monitoring; and treatment of patients suffering from or suspected of suffering from one or more of Parkinson's disease (PD) movement disorders, neurological diseases, and chronic pain. More particularly, this disclosure is directed to web-based and Internet systems and methods for remote implementation of the same.

It is a goal of the present disclosure to provide systems and methods, including computer-implemented systems and methods, to facilitate one or more of the following: diagnosis of disease; baseline and progression of disease staging; data gathering (e.g., biochemical, physical, neurological, and cognitive data gathering), including remote data gathering; monitoring, including remote monitoring; and treatment of patients suffering from or suspected of suffering from one or more of Parkinson's disease (PD) movement disorders, neurological diseases, and chronic pain. It is an additional goal to provide web-based and Internet systems and methods for remote implementation of the same.

Another goal of the present disclosure is to provide systems and methods for providing remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease and, more particularly, to systems and methods utilizing a web based interface and communicating via the internet, a wide area network, a local area network, or any other remote communication method.

Another goal of the present disclosure is to provide systems and methods for providing remote data gathering, monitoring, baseline staging, and treatment of movement disorders and, more particularly, to systems and methods utilizing a web based interface and communicating via the internet, a wide area network, a local area network, and any other remote communication method. Movement disorders include akathisia sometimes referred to as acathisia, akinesia including akinetic mutism; coma; Angelman syndrome; ataxia including spinocerebella degredation; athetosis, bradykinesia; chorea including Sydenham's chorea and Huntington's disease; cerebral palsy; dystonia, blepharospasm; mogigraphia, sometimes referred to as writer's cramp; spasmodic torticollis; dyskinesias, including paroxysmal dyskinesias, paroxysmal kinesigenic dyskinesia, paroxysmal non-kinesigenic dyskinesia, paroxysmal exertion-induced dyskinesia, paroxysmal hypnogenic dyskinesia, and tardive dyskinesia; Fragile X-associated tremor; ataxia syndrome; geniospasm; Joubert syndrome; Machado-Joseph disease; multiple system atrophy; striatonigral degeneration; myoclonus; neuroacanthocytosis; neurodegeneration with brain iron accumulation; paroxysmal choteoathetosis disease; restless leg syndrome; spasm, including infantile spasm; stereotypic movement disorders; stereotypy; tic disorder; Tourette's syndrome; tremor; essential tremor; and Wilson's disease.

Another goal of the present disclosure is to provide systems and methods for providing remote data gathering, monitoring, baseline staging, and treatment of neurological diseases and, more particularly, to systems and methods utilizing a web based interface and communicating via the internet, a wide area network, a local area network, and any other remote communication method. Neurological diseases include Landau-Kleffner syndrome; acute disseminated encephalomyelitis; attention deficit hyperactivity disorder; Holmes-Adie syndrome; adrenoleukodystrophy; leukodystrophy; Pelizaeus-Merzbacher disease; metachromatic leukodystrophy; agenesis of the corpus callosum; agnosia; Aicardi syndrome; neurological complications of AIDS; Alexander disease; Alpers' disease; alternating hemiplegia; amyotrophic lateral sclerosis; Von Hippel-Lindau disease; antiphospholipid syndrome; aphasia; apraxia; arachnoid cysts; arachnoiditis; chiari malformation; arteriovenous malformation; Asperger syndrome; autism and autism spectrum disorders; dysautonomia; back pain; Barth syndrome; Batten disease; myotonia; myotonia congenita; Behcet's disease; Bell's palsy; monomelic amyotrophy; meralgia paresthetica, Binswanger's disease; incontinentia pigmenti; brachial plexus injuries; orthostatic hypotension; brain and spinal tumors; tuberous sclerosis; cerebral aneurysm; traumatic brain injury; Brown-Sequard syndrome; Kennedy's disease; spinal muscular atrophy; cerebral autosomal dominant arteriopathy with sub-cortical infarcts and leukoencephalopathy; carpal tunnel syndrome; complex regional pain syndrome; cerebral cavernous malformation; spinal cord injury; central cord syndrome; central pain syndrome; central pontine myelinolysis; cephalic disorders; lipid storage diseases; Tay-Sachs disease; Niemann-Pick disease; Farber's disease; cerebellar degeneration; Wernicke-Korsakoff syndrome; Sotos syndrome; cerebral hypoxia; Charcot-Marie tooth disease; neuroacanthocytosis; chronic inflammatory demyelinating polyneuropathy; postural tachycardia syndrome; Coffin Lowry syndrome; cerebro-oculo-facio-skeletal syndrome; colpocephaly; Moebius syndrome; congenital myasthenia; congenital myopathy; corticobasal degeneration; vasculitis syndromes of the central and peripheral nervous systems; craniosynostosis; Creutzfeldt-Jakob disease; Cushing's syndrome; opsoclonus myoclonus; Dandy-Walker syndrome; subacute sclerosing panencephalitis; septo-optic dysplasia; dementia, including multi-infarct dementia, frontotemporal dementia, subcortical dementia, dementia with Lewy bodies; dentate cerebellar ataxia; dyssynergia cerebellaris; myoclonica; dermatomyositis; developmental dyspraxia; Devic's syndrome; neuromyelitis optica; diabetic neuropathy; diffuse sclerosis; Schlder's disease; Dravet syndrome; dysgraphia; dyslexia; early infantile epileptic encephalopathy; Ohtahara syndrome; encephalitis; meningitis; encephalopathy; Sturge-Weber syndrome; epilepsy; Todd's paralysis; Fahr's syndrome; familial periodic paralyses; febrile seizures; Miller Fisher syndrome; hypotonia; foot drop; Friedreich's ataxia; Gerstmann's syndrome; Gerstmann-Straussler-Scheinker disease; giant axonal neuropathy; Guillain-Barré syndrome; hemifacial spasm; hereditary neuropathies; hereditary spastic paraplegia; Refsum disease; tropical spastic paraparesis; hydrocephalus; hydromyelia; hypertonia; inclusion body myositis; infantile neuroaxonal dystrophy; inflammatory myopathies; Whipple's disease; Isaac's syndrome; Kearns-Sayre syndrome; Klippel-Trenaunay syndrome; Klüver-Bucy syndrome; Lambert-Eaton myasthenic; Wallenberg's syndrome; Leigh's disease; Lennox-Gastaut syndrome; Lesch-Nyhan syndrome; lipoid proteinosis; lissencephaly; neurological sequelae of lupus; megalencephaly; Menkes disease; microcephaly; transient ischemic stroke; mitochondrial myopathies; motor neuron diseases; Moyamoya disease; multifocal motor neuropathy; multiple sclerosis; muscular dystrophy; myasthenia gravis; myopathy; thyronic myopathy; neuroleptic malignant syndrome; neuronal migration disorders; schizencephaly; neurosarcoidosis; neurotoxicity; paraneoplastic syndromes; stiff-person syndrome; Parry-Romberg syndrome; peripheral neuropathy; periventricular leukomalacia; porencephaly; post-polio syndrome; primary lateral sclerosis; tabes dorsalis; progressive multifocal leukoencephalopathy; Alpers' disease; progressive supranuclear palsy; Rasmussen's encephalitis; Rett syndrome; Sandhoff disease; shaken baby syndrome; sleep apnea; spasticity; spinal cord infarction; syncope; hydromyelia; tethered spinal cord syndrome; thoracic outlet syndrome; transverse myelitis; Troyer syndrome; and whiplash.

Another goal of the present disclosure is to provide systems and methods for providing remote data gathering, monitoring, baseline staging, and treatment of chronic pain and pain management and, more particularly, to systems and methods utilizing a web based interface and communicating via the internet, a wide area network, a local area network, and any other remote communication method.

Another goal of the present disclosure is to make life better for those with Parkinson's disease, movement disorders, neurological disease, and/or chronic pain by measuring the efficacy of various treatments to treat the disease or disorder, delay its onset, and/or prevent it from developing.

Another goal of the present disclosure is to make an early diagnosis of Parkinson's disease, movement disorders, and neurological disease, and/or chronic pain, which allows both the patient and caregivers time to make choices that maximize quality of life; select an appropriate medical team; afford a better chance of benefiting from treatment and/or participate in studies or experimental treatments which tend to focus on early stage Parkinson's disease, movement disorders, and/or neurological diseases; lessen anxieties about unknown problems; enhance safety and security by planning for diminished or impaired physical or mental capacity; and provide more time to plan for the future.

Yet another goal of the present disclosure is to remotely acquire fully validated clinical data and assessments of Parkinson's disease, movement disorders, neurological disease symptoms, and/or chronic pain patients from a greater population and cross-section of patients, at significantly lower cost with types and level of data previously unavailable to the physician or researcher, especially from a remote access location. Improved access to patients and innovative data capture will ultimately lead to improved therapies and render assistance in the search for therapies for Parkinson's disease, movement disorders, neurological diseases, and/or chronic pain.

Yet another goal of the present disclosure is to aid in differential diagnosis of Parkinson's disease, movement disorders, neurological diseases, and chronic pain from other disorders.

Yet another goal of the present disclosure is to detect memory loss of recently learned information, thereby enabling early detection of the onset of dementia related to Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain.

Yet another goal of the present disclosure is to detect difficulty with performing everyday tasks such as playing simple games, dressing, cooking meals, or basic hygiene. Measuring the amount and type of difficulty with performing everyday tasks allows for discrimination between normal age related thought process degradation and Parkinson's symptoms or progression of other movement disorders, neurological diseases, and/or chronic pain. Periodic measurement of difficulty with performing everyday tasks will provide another metric for gauging the progression of the disease or disorder.

Yet another goal of the present disclosure is to detect difficulty with speech. Voice recognition will be utilized to detect the loss of memory for simple words or the use of unusual words in place of the correct word or words. By measuring the amount and type of difficulty with speech the present disclosure, one is able to discriminate between normal age related speech impairment and Parkinson's disease symptoms or other movement disorders, neurological diseases, and/or chronic pain. Periodic measurement of difficulty with speech will provide yet another metric for gauging the progression of the disease or disorder.

Yet another goal of the present disclosure is to detect difficulty with abstract thinking. One or more tests comprising a series of tasks are utilized to test abstract thinking skills which may be compared against a standard or known baseline. Periodic measurement of abstract thinking skills will provide yet another metric for gauging the progression of the disease or disorder.

Yet another goal of the present disclosure is to detect changes in personality and to distinguish this from normal changes in personality from an individual's age to symptoms related to Parkinson's disease, neurological disease, movement disorders, and/or chronic pain. Periodic measurement of personality, e.g.: by using standard assays or questionnaires, will provide yet another metric for gauging the progression of the disease or disorder.

Yet another goal of the present disclosure is to detect changes in mood or behavior which is another symptom of Parkinson's disease, other neurological diseases, movement disorders, and/or chronic pain and to distinguish this from normal changes in mood or behavior. Periodic measurement of mood or personality swings will provide yet another metric for gauging the progression of the disease or disorder.

Yet another goal of the present disclosure is to assess risk factors for developing Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain, such as age, family history, genetics (both risk and deterministic genes), traumatic head injury, high blood pressure, heart disease, stroke, diabetes and high cholesterol, weight, tobacco and excess alcohol consumption, physical exercise, mental exercise, and social interactions.

Yet another goal of the present disclosure is to provide an easy to access, Health Insurance Portability and Accountability Act (HIPAA) compliant, fully comprehensive medical and psychological data and timelines for the primary care physician, neurologists, psychiatrists, and psychologists, and other authorized medical care professionals for the prophylactic treatment of Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain.

Yet another goal of the present disclosure is to overcome the difficulties in recruitment of a sufficient number of Parkinson's disease, neurological disease, movement disorder, and/or chronic pain patients for clinical studies who fit acceptance criteria and expected patient compliance. By remotely collecting data in batch mode, real-time, or near real-time that would normally involve physician/patient interactions, affords a significant improvement in patient recruitment as well as the kinds and frequency of data collection possible in an investigation.

Yet another goal of the present disclosure is to remotely acquire improved and fully validated clinical data and assessments of Parkinson's disease, neurological disease, movement disorder, and/or chronic pain symptoms, from a broad population and cross-section of patients, at significantly lower cost. This data type and level of data has to date been unavailable to the physician or researcher, especially from a remote access location. This type of data capture will ultimately aid in transforming how certain types of clinical research is conducted. Improved access to patients and innovative data capture will ultimately lead to improved therapies and render assistance in the search for a cure for Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain.

Another goal of the present disclosure is to overcome the traditional hurdles for the recruitment of a sufficient number of patients who fit acceptance criteria, along with patient compliance any clinical study, including those in Parkinson's disease, neurological disease, movement disorders, and/or chronic pain. In addition, the elimination or reduction in the quantity of on-site physician interactions and testing is a significant benefit of the present disclosure. Indeed, traditional on-site testing and interactions has been the only way in which Parkinson's disease patients have been assessed up until the present disclosure.

Another goal of the present disclosure is to overcome the lack of patient recruitment which can limit the amount and frequency of data collected, thereby restricting the full utility of the investigation. The ability to remotely collect data in real-time or near real-time that would normally involve physician/patient interactions will significantly improve patient recruitment as well as the kinds and frequency of data collection possible in an investigation. Assimilating and translating data under the present disclosure is designed for use by the physician or researcher and is potentially life altering for those with Parkinson's disease, neurological disease, movement disorders, and/or chronic pain, increasing the ability to diagnose and treat, assessing medication dosage and compliance, and longitudinally track the progression of Parkinson's disease, neurological disease, movement disorders, and/or chronic pain patient. This type of patient surveillance will ultimately serve to decrease morbidities associated with Parkinson's disease, neurological disease, movement disorders, and/or chronic pain, increase patient/physician contact, and will serve as an excellent research platform.

Yet another goal of the present disclosure is to assimilate and translate data remotely acquired by the present disclosure for use by the physician or researcher, will increase the ability to diagnose and treat, assessing medication dosage and compliance, and longitudinally track the progression of Parkinson's disease, neurological disease, movement disorders, and/or chronic pain patient. This type of patient surveillance will ultimately serve to decrease morbidities associated with many of these diseases and disorders, increase patient/physician contact, and will serve as an excellent research platform.

Yet another goal of the present disclosure is to provide an easily accessible “in-home” web based administration of mental status testing, including but not limited to the mini mental state examination and the “mini-cognitive” test that will allow frequent (diurnal, daily, weekly, monthly) monitoring of a patients mental state and automatically trigger warnings or alarms for patients that miss or fail their tests.

Yet another goal of the present disclosure is to provide an easily accessible “in-home” web based administration of the Unified Parkinson's Disease Rating Tests, in whole, in part, incrementally, and/or on a predefined schedule by the patient, health care provider, doctor, or clinical researcher.

Yet another goal of the present disclosure is to provide both standard and customizable tests tailored to a patient, group of patients, or clinical study that allows for the appropriate frequency, type, and duration of testing and inclusion of appropriate test elements. The customization can be performed by a health care provider, health professional, doctor, or clinical researcher as appropriate to the type and use of data required.

Yet another goal of the present disclosure is to remotely gather data with the aid on an online health care provider, health professional, doctor, or clinical researcher available through interactive audio, video text, graphics, or any other media used singly or in any combination. The interaction may be full duplex or half duplex.

Yet another goal of the present disclosure is to allow for testing that is fully self administered by the patient or health care provider, as well as providing a means to deploy “man-in-the-loop” tele-testing with real-time patient/physician interaction for special situations or increased functionality to provide maximum flexibility in the kinds of testing that can be utilized, all while preserving the autonomous remote location data collection capabilities of the system.

Yet another goal of the present disclosure is to provide systems and methods for providing remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease and, more particularly, to systems and methods utilizing a web based interface and communicating via the internet, a wide area network, a local area network, and any other remote communication method.

DRAWINGS

The above and other goals and advantages of the present disclosure will be apparent upon consideration of the following detailed description, taken in conjunction with accompanying drawings, in which like reference characters refer to like parts throughout, and in which:

FIG. 1 is a block diagram of a system for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, and/or other movement disorders, in accordance with one embodiment of the present disclosure.

FIGS. 2a, 2b and 2c present a flow diagram of a system for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, and other movement disorders, in accordance with another embodiment of the present disclosure.

FIG. 3 is a block diagram of a Patient Remote Interface for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, and other movement disorders, in accordance with yet another embodiment of the present disclosure.

FIG. 4 is a block diagram of a Patient Remote Interface with interface drivers and web browser for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, and other movement disorders, in accordance with yet another embodiment of the present disclosure.

FIGS. 5a, 5b, 5c and 5d are a flow diagram of a Mini Mental State Examination for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, and other movement disorders, in accordance with another embodiment of the present disclosure.

FIGS. 6a-e is a standard Unified Parkinson's disease Rating Scale.

FIGS. 7a-b is a standard Unified Parkinson's disease Rating Scale Data Form.

FIGS. 8a-g is a web implementation of the Unified Parkinson's Disease Rating Scale and associated level for use in remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, and other movement disorders, in accordance with another embodiment of the present disclosure.

FIGS. 9a-d is a representative Summary Protocol for feasibility of one embodiment of the present disclosure of a web based-assessment tool for the determination of baseline staging, data gathering and monitoring of early, middle, and late stage Parkinson's disease.

FIG. 10 is a block diagram of a computing system that can be used in connection with the data acquisition models and computer-implemented methods described in this document.

DESCRIPTION

The present disclosure is directed to systems and methods, including computer-based systems and methods for providing one or more remote data gathering, monitoring, diagnosis, baseline and progression of disease staging, and treatment methods for Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain and, more particularly, to systems and methods utilizing a web based interface and communication via the internet, a wide area network, a local area network, or any other remote communication method.

In the following description, it is to be understood that system elements having equivalent or similar functionality are designated with the same reference numerals in the Figures. It is to be further understood that the present disclosure may be implemented in various forms of displays, hardware, software, firmware, networks or combinations thereof. In particular, the system modules described herein are preferably implemented in software as application programs that are executable by, e.g., a general purpose computer or any machine or device having any suitable and preferred microprocessor architecture.

Preferably, the present disclosure is implemented on computer platforms including hardware such as one or more central processing units (CPU), a random access memory (RAM), and input/output (I/O) interface(s). The computer platform may also include an operating system and microinstruction code. The various processes and functions described herein may be either part of the microinstruction code or application programs which are executed via the operating system. In addition, various other peripheral devices may be connected to one or more computer platforms, such as accelerometers; gyroscopes magentometers; global positioning receivers and processing units; video cameras and video capture devices, such as web cameras, laser imaging radars, displays and touch input screens; speakers and other audio annunciators; microphones and other audio capture devices; capacitive contact pads and strain gauges; writing pads; touch pads; network interfaces and additional data storage devices; and printing devices.

It is to be further understood that, because some of the constituent system components described herein are preferably implemented as software modules, hardware devices, and network interconnections, the actual system connections shown in the Figures may differ depending upon the manner in which the systems are programmed or implemented. Given the teachings herein, one of ordinary skill in the related art will be able to contemplate these and similar implementations or configurations of the present disclosure.

Although illustrative embodiments have been described herein with reference to the accompanying drawings, it is to be understood that the present disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the disclosure as defined by the appended claims.

Referring now to FIG. 1, a block diagram illustrates a system for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, movement disorders, neurological diseases, and/or chronic pain comprised of a Remote Patient Interface 105, Health Care Provider Remote Interface 110, Physician Remote Interface 115, Researcher Remote Interface 120, and Insurer or Fiduciary Remote Interface 125, which are operatively connected to a Remote Data Center 160 via the Internet 130 or any other means of remote connection.

It should be noted that the Patient, Health Care Provider, Physician, Researcher, and Insurer or Fiduciary Remote Interfaces may transmit data to, or receive data from, the Remote Data Center by any form of data transmission or via storage media. Transmission systems include, but are not limited to wide area networks, local area networks, wireless networks, cellular telephone transmission, satellite transmission, personal area networks (Bluetooth®), telephone dial-up interfaces, analog signals or digital signals via copper wire, fiber optics, and wireless including all portions of the spectrum such as visible, infrared, ultraviolet, ultrasonic, and radio frequency. Transmission systems may also include the physical delivery of memory storage devices including memory sticks, and all other forms of non-volatile and quasi-non-volatile memory devices.

In addition, the Patient, Health Care Provider, Physician, Researcher, and Insurer or Fiduciary Remote Interfaces may transmit data to, or receive data from each other directly utilizing an appropriate of routing or addressing system via any form of data transmission. Advantageously, the information transmitted may be retained indefinitely or for some prescribed period of time by the transmitting and or receiving party for record keeping purposes and/or transmitted to the data center or another central repository of information for additional record keeping.

The remote patient interface 105 provides: a portal to the data center application server 150, performs one or more suites of tests as prescribed by the physician or healthcare provider, and securely transmits the results of the tests back to the application server 150. In one embodiment, open source PGP encryption to authenticate the identity of users and encrypt personal medical data so it cannot be stolen or duplicated by anyone else. In addition, encrypted digital signatures ensure that the data cannot be altered once it's electronically “signed”. Alternate encryption and validation technologies such as coviant diplomat transaction manager or other commercially or available encryption packages may be utilized if so desired.

It should be noted that Remote Patient Interface transmitting patient information may be part of a broader multi-purpose computing or network device. For example, the Patient Remote Interface may be hosted on an iPhone®, smartphone or any other personal digital assistant (PDA) or mobile computing device, a laptop computer, a desktop computer, or any device with a user interface and program capability, such as a cable box with a remote control.

The Healthcare Provider Remote interface 110, the Physician Remote Interface 115, the Researcher Remote Interface 120, and the Insurer or Fiduciary Remote Interface 125 each provide portals to the Data Center Application Server.

In one embodiment of the present disclosure, any computer or device with a web browser and internet access may function as a Healthcare Provider, or Insurer or Fiduciary Remote Interface.

The Physician Remote Interface 115 allows patients to be added and removed from the system along with management of passwords and access privileges. More significantly, Physician Remote Interface provides access to raw and processed data collected from patient tests and can provide various types of reports and graphs to be generated based upon a specific patient's tests results and test histories. In addition, a physician can order, prescribe, or construct any desired series of tests on a one time or periodic basis.

The Healthcare Provider Remote Interface 110 allows limited access to one or more patient's data predicated upon specified privileges. For example, the healthcare provider may only be able to see patient compliance with various tests and test schedules. In addition, it will allow the healthcare provider to administer the tests to one or more patients.

The Researcher Remote Interface 120 allows provides access to raw and processed data collected from patient tests and can provide various types of reports and graphs to be generated based upon a one or more patient tests result and test histories. In addition, a researcher can aggregate or download large quantities of data from multiple patients based upon specific profiles or selection criteria for conducting research into Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain. The data may be accessed on an anonymous basis or by specific patient.

The Fiduciary or Insurer Remote Interface 125 provides for the ability to send or receive billing information, pay bills, or process insurance claims. Patient health information and test results may be restricted to tests performed and testing dates for HIPAA compliance.

The data center 160 is comprised of a means for receiving and transmitting appropriate data such as an interface to the internet 130, a means for selecting only data beneficially intended for the present disclosure such as a router 135, and optionally, one or more firewalls 140 or other devices for protection from malicious or inadvertent attacks. The data center 160 will authenticate system users and sessions (e.g.: patients, healthcare providers, physicians, researchers, fiduciaries and insurers), maintain system user profiles and user information via a web server 145 or software or hardware with equivalent functionality, administer tests via an application server 150 or software or hardware with equivalent functionality, and create a database of results from some or all patient tests via a database server 155 or software or hardware with equivalent functionality, and generate reports based upon tests or data collected on one or more patients via the application server 150. Advantageously, the data center 160 will provide for automated back-up and recovery.

Administration functions will also be available, including system maintenance, maintaining system access privileges, and collecting various types of system performance and billing/payment information.

Data center functions may be implemented in a wide variety of architectures including all functions on a single CPU running on a single operating system to complex distributed functionality in a large load balanced data center. In one embodiment of the present disclosure, the data center architecture consists of one or more of the following open source components including the Linux operating system. Apache web server, PHP scripting language, Code Igniter PHP framework, jQuery DHTML Library PostgreSQL database, and open source PGP encryption. The Linux operating system may be utilized to host the all of the applications needed to implement the data center. The data center system will be architected in a modular fashion allowing the various components to be run on a single computer or across multiple computers to provide rapid scalability.

In one embodiment of the present disclosure, all or part of the data gathering, monitoring, baseline staging, and treatment system advantageously employs a modular architecture for rapid prototyping, validation, and deployment. A scalable architecture and user platforms may rely on open source or and commercially available or proprietary software, hardware and development and maintenance tools. This facilitates the addition of new tests and enhanced technologies while expediting prototyping and deployment.

The web server 145 will serve web pages to users of the system including Patients 105, Healthcare Providers 110, Physicians 115, Researchers 120, Fiduciaries and Insurers 125 via their respective remote interfaces. Additionally, data obtained during patient tests maybe uploaded to the data center 160 via Firefox® or other web browser. The PHP scripting language in combination with the jQuery DHTML Library and the Code Igniter PHP framework will provide for interactive web pages that dynamically created utilizing information stored in the PostgreSQL database. For example, patients may see different homepages than doctors and researchers. Additionally, different patients may run through different sets of tests as prescribed. The PostgreSQL database will store at a minimum, the User Access Control List (ACL), Patient Profile, Patient Test Results, System Logging Information, Patient/Doctor Login Dates, Login IP Addresses. Logout Dates, Patient Profile Changes, and related information.

The present system may optionally incorporate Health Insurance Portability and Accountability Act (HIPAA) compliant data security for all applicable aspects of the system including data access, data mining, data transmission, and data storage. The modular architecture of the present disclosure will allow for easy upgrading to new standards in privacy as they become mandated or applicable.

Referring now to FIGS. 2a, 2b, and 2c , a flow diagram illustrates a system for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, movement disorders, neurological diseases, and/or chronic pain in accordance with another embodiment of the present disclosure.

As shown in FIG. 2, a Remote Patient Interface 201 requests login to the data center. Biometric or any other form of Patient Identification 202 is optionally utilized for patient authentication. Other techniques, such as IP address and phone numbers, may also be utilized. If the login 203 is successful, the session is started 204. If the login is not successful, more retries may be attempted 205 and the login is retried 203. If no more retries are available 205, then a test is performed to see if the system can operate in local capacity 207. If local capability is available, then a local session is started for later download to the server or data center 208. If local capability is not available, then the login process can be optionally retried 209, 201.

If login is successful and a session is started 204, the web server pushes a welcome page 210, which is optionally personalized. The patient then initiates a first test sequence or therapy 211. The web server the pushes the first test or therapy sequence 212 to the patient interface. The test or therapy results and optionally times are reported back to the data center 213. A check is performed to see if there are any additional tests or therapies to be performed 214. If no additional tests or therapies are to be performed, then a session end is requested 215 and the session is ended 216. If additional tests or therapies are required 214, then the next test or therapy sequence is initiated 218. The web server then pushes the next test or therapy sequence 219 and the results are subsequently logged, optionally with times, and reported to the data center.

If login is not successful 203, then an optional test is performed to see of more retries are available 205. If more retries are available, then a login retry may be attempted 206. If more retries are not available, or if the patient wishes to operate in local mode only, a test is performed to see if local capability is available 207. If local capability is not available, then the only option available would be to restart the login process 209. If a local session is available 207, then a local session is started for later download to the server/data center 208.

If a local session is started 208, the local application that essentially performs the function of the web server and data logging in the local environment is then started 221. The local application 221 is optionally personalized. The patient then initiates a first test sequence or therapy 222. The application runs the first test or therapy sequence 223 to the patient interface. The test or therapy results, and optionally times, are logged for later reporting back to the data center 224. A check is performed to see if there are any additional tests or therapies to be performed 225. If no additional tests or therapies are to be performed, then a try is attempted to report the test or therapy results to the data center 226. Several retries may be attempted 227. If no more retries are available, the session is ended 228. If additional tests or therapies are required, then the next test or therapy sequence is initiated 231. The application then executes the next test or therapy sequence 232 and the results are subsequently logged, optionally with times 233, for later reporting to the data center.

It should be noted that it is not necessary that the Patient Remote Interface operate in an interactive web based mode. Indeed, the system could always work in the local environment and report results to the data center in batch mode.

Referring now to FIG. 3, a block, diagram illustrates a Patient Remote Interface for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease, neurological diseases, movement disorders, and/or chronic pain in accordance with yet another embodiment of the present disclosure. The Remote Patient Interface gathers data (e.g., biochemical, physical, neurological, cognitive data) via one or more means of interfacing and/or interacting with one or more patients and then transmits the acquired data in raw or processed form via any means to the data center or to one or more remote interfaces. Any known assay may be used to acquire the data gathered.

As shown the remote patient platform hardware/software device 300 interfaces with a variety of input and output devices. As shown, input devices for data acquisition from the patient may include one or more of the following: a keypad; touch screen input or other input device 305; a video acquisition device, such as a camera, webcam, or laser imaging radar 310; an audio capture device, such as a microphone, preamp, and analog to digital converter 315; a writing pad 320; a kinematic orientation tracker 325 which may be comprised of one or more gyroscopes, one or more accelerometers, a magnetometer, an optical motion/position sensing systems, a microwave motion/position sensing system, or any other mechanism, device, or stimulus sensing technology capable of sensing patient motion in any part of the patient's body. In one embodiment, a 3-axis gyro/accelerometer package, preferably with a wireless interface that acquires 3-axis attitude and acceleration information, along with pitch, roll, and yaw rates, may be utilized.

In addition, a global positioning system receiver 330 may be utilized to acquire patient location information or motion of the patient's location or any part of the body or appendage. The global positioning system may consist of one or more receivers along with various types of position augmentation devices, such as a wide area augmentation system or other form of position/motion sensing.

Temperature monitors 335 may be employed for sensing of either external or internal body temperatures. The sensing technology may be any means, including contact temperature sensors, including solid state sensors, infrared remote sensing, and temperature sensor systems, that employ active or passive scanning.

Blood pressure sensors and various forms of blood chemistry monitoring 340 may be employed, utilizing either invasive or non-invasive monitoring techniques. Techniques utilized for blood pressure monitoring may rely on traditional cuff wraps or, more advantageously, pulse wave velocity which calculates blood pressure by measuring the pulse at two points along an artery. In addition, data from the kinematic orientation/motion sensor 325 may be employed concurrently with a pulse wave velocity blood pressure monitoring to compensate for blood pressure inaccuracies due to motion or orientation.

Electrocardiography (EKG/ECG) and/or electroencephalography (EEG) sensing 345 may be employed to gather data on cardiac and brain activity, respectively. A multitude of small portable EKG and EEG devices with USB or other data interfaces are widely available in the marketplace,

A biometric or any other form of security device 350, such as a retinal scanner, voice recognition, electronic or mechanical lock and key, may be utilized for restricting access to one or more patients, care givers, doctors, clinicians, and/or other personnel.

In one embodiment of the present disclosure, the patient platform 300 may be a general purpose touchscreen computer running hosted on a Microsoft Windows Vista® operating system with the framework of the test application implemented using JavaScript® and will be hosted in a Mozilla Firefox® web browser. The JavaScript® code base will be stored and loaded from the data center's web server upon initiation of a test session by the patient. Microsoft Visual Studio C++ ® will be used to develop Windows® Services that will act as proxies for physical input devices. Windows® Services will be responsible for providing a robust and seamless interface to the JavaScript® application, while also handling initialization, error handling, and results reporting for their respective input devices. The JavaScript® application will communicate with the Windows® Services via a TCP/IP connection and SOAP (http://en.wikipedia.org/wiki/SOAP), an XML based communication protocol, with the data payload encrypted and authenticated by open source PGP encryption.

Output and stimulus devices include a visual display 355; an audio stimulus device 360, such as headphones or speaker system; one or more force stimulus devices 365 to test muscle strength, range of motion, and other physical properties; an olfactory stimulus device 370 for sense of smell; a touch stimulus device 375 for measuring nerve sensitivity and reflex responses; a thermoception stimulus device 380 for temperature perception testing; a taste stimulus device for taste sensitivity 385; and one or more network interfaces 390 which may be wired, wireless, cellular, infrared, microwave, or any other form of data transmission and reception, or any combination thereof.

FIG. 4 illustrates the interface drivers utilized to interface the various sensors and actuators in the Remote Patient Interface in one embodiment of the present disclosure. As shown, the patient platform 300 may be a general purpose touchscreen computer running hosted on a Microsoft Windows Vista® operating system with the framework of the test application implemented using JavaScript® hosted in a Mozilla Firefox® web browser. As shown, all sensor and stimulus devices may utilize standard device drivers, such as Windows® Services.

Depending upon system implementation and the desire to process data remotely, the drivers utilized may also be the previously recited standard drivers that are available from various commercial suppliers of the sensors and actuators/feedback devices or they may be fully custom drivers written to support specific sensor/feedback functions or data processing functions, or some combination thereof. In particular, high bandwidth output devices video acquisition 310, audio capture 315, and a kinematic orientation/motion tracker may have drivers or embedded applications that preprocess the data. By way of example, during a test for tremors on a limb, the data may be processed to give statistics on the frequency and magnitude of tremors rather than raw data from the gyros and accelerometers. The data processing functions may take place in the Device Driver Kalman Estimator and Windows® Service 425.

FIGS. 5a, 5b, and 5c is a flowchart of a Mini Cognition Test. A Mini Cognition Test is initiated 501 and the Patient Remote Interface speaks three words selected from a prescribed list. The list may be selected based upon a variety of factors, including patient's age and education. The patient interface begins recording and, optionally, analyzing the words which will be repeated by the patient 503. The patient interface then requests that the same three words be spoken by the patient 504. The patient then attempts to speak the same three words 505. A test is performed to see if the words are spoken 506. If yes, the results are reported or logged 511. If no, then a check is performed see if the test has timed out 507 (time limit reached). If no timeout has occurred, the words spoken test is continued 506. If there is a timeout 507, then the failure is reported or logged along with any optional analysis results 508. The patient interface may then query the patient for a status 509. If the patent requests a retry, then the system again checks for words spoken 506. If the patient does not request a retry, then no retry is logged or reported 515.

After the results have been logged or reported 511, a touchscreen, writing pad or other user interface is enabled as appropriate to acquire drawn clock data 512. The patient interface then requests that the patient draw a clock 513. The patient then attempts to draw a clock 514. A test is performed to see if the clock has been drawn 516. If “no”, then a test is performed to see if a timeout has occurred 517. If a timeout has occurred, then the failure is reported along with any related data analysis and results 518. The patient interface may then query the patient for status 519. If the patent requests a retry 520, then the system again checks for the drawn clock 516. If the patient does not request a retry, then no retry is logged or reported 521. If a clock has been drawn 516, the results are logged or reported 522.

The patient interface begins recording and, optionally, analyzing the words which will be repeated by the patient 523. The patient interface then requests a repeat of the same three words that were requested earlier 524. The patient then attempts to speak the same three words 525. A test is performed to see if the words are spoken 526. If yes, the results are reported or logged 532. If no, then a check is performed see if the test has timed out 527 (time limit reached). If no timeout has occurred, the words spoken test is continued 525. If there is a timeout 527, then the failure is reported or logged along with any optional analysis results 528. The patient interface may then query the patient for a status 529. If the patent requests a retry, then the system again checks for words spoken 530. If the patient does not request a retry, then no retry is logged or reported 531.

FIGS. 6a, 6b . 6 c, 6 d, and 6 e represent one version of the standard Unified Parkinson's disease Rating Scale which was designed to be administered in person, face to face, by a trained physician, clinician, or health care provider.

The Unified Parkinson's Disease Rating Scale is a rating scale used to follow the longitudinal course of Parkinson's disease. It is made up of the following sections: Mentation, behavior, and mood, Activities of daily living, Motor, and Complications of therapy.

These sections are to be evaluated by interview and clinical observation. Some sections require multiple grades assigned to each extremity. Clinicians and researchers alike currently use the UPDRS and the motor section in particular to follow the progression of Parkinson's disease in a patient. Following the UPDRS scores over time provides insight into the patient's disease progression. For instance, Michael J. Fox's symptoms started with a slight tremor, so his motor score would have been less than 10. For most patients, the “mentation, behavior and mood” scores increase later in the disease, but there is a subset for who those symptoms develop early on.

Diagnosis of Parkinson's disease thus presently relies on a neurological examination conducted by and review of a patient's medical history by interviewing and observing a patient in person using the Unified Parkinson's Disease Rating Scale and the patient's medical history.

Parkinson's disease may be difficult to diagnose accurately, especially in the early stages. Early signs and symptoms may be dismissed by the physician or clinician administering the tests as part of the normal aging process since nearly all of the tests presently used are subjective. The present disclosure provides a means for garnering quantitative scientific data which may be utilized to diagnose the presence of disease or disorder and differentially diagnose and track the progression of Parkinson's disease from other diseases or disorders. In addition, for many diseases or disorders, a patient may not exhibit symptoms consistently. For example, in the case of Parkinson's disease, there may be only signs with or without symmetry; there may be no bradykinesia; or there may be atypical signs, such as postural, rather than rest, tremor, mild rigidity, a lack of progression of symptoms over time, and a lack of response to normal treatments such as Levodopa. The ability to acquire data more frequently at the patient's convenience, or at specific times, or a prescribed periodic basis, or when on or off medications, or at specific times of the day or night, or when the patient is exhibiting specific symptoms will greatly aid in Parkinson's research and the diagnosis of specific patients.

FIGS. 7a and 7b are a standard scoring sheet for the Unified Parkinson's Disease Rating Scale. As shown, the results are segregated by on and off medications and the results are also summarized by best and worst for the modified Hoehn and Yahr Staging, ranging from Stage 0 (which is no signs of the disease) to Stage 5 (which is wheelchair bound or bedridden unless aging). Summary results are also provided for the Activities of Daily Living ranging from 100% completely independent (able to do chores without slowness, difficulty or impairment, essentially normal, unaware of any difficulty) to 0% (vegetative functions, such as swallowing, bladder and bowel functions, are not functioning, bedridden).

FIGS. 8a-g present a detailed test methodology which represents a modified version of the Unified Parkinson's Disease Rating Scale in accordance with one implementation of the present disclosure. As shown, the Remote Patient Interface implements various tests as prescribed by the physician or caregiver. As shown, there are three levels of use, Basic. Complex, and Comprehensive. FIGS. 8a-g are not intended to show all possibilities or indeed to implement all tests, but rather to show one representative implementation of a strata of Remote Patient Interface Testing.

It should be noted that in FIGS. 8a-g that the basic test suite includes only those tests checked under basic. The complex test suite includes both the basic test suite and those test checked under complex. Likewise, the comprehensive test suite includes the complex test suite plus those test checked under comprehensive, thus the basic, complex, and comprehensive checked tests are included under the comprehensive test suite.

In one embodiment of the present disclosure, clinical validation of a system for baseline staging, data gathering, monitoring and treatment of Parkinson's disease, an initial selection of UPDRS or another fully standardized and widely practiced test is utilized to eliminate the variability associated with a new or not widely understood Assessment Protocol while focusing clinical test efforts on technology validation and simultaneously. As shown in FIGS. 8a-g of the present disclosure, the present implementation of the UPDRS is constructed as a three level test suite which are designated as basic, complex, and comprehensive. These categories primarily reflect the organization of the questions comprising the UPDRS in terms of two factors: (1) the degree to which major data collection modalities would be needed to implement in remote testing and (2) relevance across a wide range of stages of Parkinson's disease so as to maximize the information conveyed.

The basic test module will provide the clinician and researcher a baseline measurement from which to assess changes in Parkinson's disease status, and to assist in making decisions regarding medications or treatment approaches. It consists of a number of relatively simple tests that can be performed as many times as necessary either daily or multi-times per day. The test gathers the data in both go live and subjective form as it relates to the UPDRS #'s 1, 3, 4, 5, 7, 10, 12, 13, 14, 15, 16, 18, 20, 21, 22, 25, 32, 34, 40 and 41, (representing a total of 20 tests).

The complex tests will allow the clinician and researcher to more closely examine a greater set of symptom parameters. The complex test module includes UPDRS tests from the basic test module along with those that correspond to the UPDRS #'s 6, 8, 17, 19, 22, 23, 26, 27, 33 and 35 (for a total of 30 tests).

The comprehensive test incorporates all levels of the UPDRS including those of the basic and complex test modules along with those from the UPDRS corresponding to #'s 2, 9, 11, 28, 29, 30, 31, 35, 36, 37, 38, 42 (a total of 42 tests). The comprehensive test can be utilized for a remote baseline examination or an examination of one complete specific area of the body. For example, a representative clinical study will utilize a longitudinal prospective study of 30 patients over 6 months. (10 with early, 10 with middle, and 10 with late stage Parkinson's disease as determined by the Hoehn and Yahr staging).

In one embodiment of the present disclosure, availability of commercial off-the-shelf sensors and actuator is essential for rapid product development and deployment. However, in all cases the technology exists for implementing each of the 42 questions of the standard UPDRS (FIG. 6) remotely.

FIGS. 9a-d present one embodiment of a full clinical protocol with the Detailed Test Methodology shown in FIGS. 8a-c . The present test methodology employs measurements that involve both motor and non-motor aspects of the UPDRS. The choice of tests to implement in one embodiment of the clinical protocol is based on (1) relevance across a wide range of stages of Parkinson's disease and (2) the desire to validate major data collection modalities (inertial measurements, video capture, audio capture, computer based questionnaires and reaction time monitoring, walking pads, handwriting tablets) to demonstrate flexibility for integration of multiple technologies. The process of integrating various data collection modalities will also provide a basic structure on which to develop and integrate other testing modules or technologies in future efforts to expand and adapt this off-site data collection solution.

As shown in FIGS. 8a-c , a variety of testing methodologies and devices are utilized, including questionnaires with short term memory shapes, words, and colors; voice capture for physician analysis or optional automated analysis; use of commercial signature verification; gait analysis systems; accelerometers or kinematic motion and position sensing; video capture for later physician or automated analysis; force stimulation and force feedback systems; dynamometers; and automated blood pressure analyzers.

FIG. 10 is a schematic diagram of a computer system 1000. The system 1000 can be used for the operations described in association with any of the computer-implement methods described previously, according to one embodiment. The system 1000 is intended to include various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other appropriate computers. The system 1000 may also include mobile devices, such as personal digital assistants, cellular telephones, smartphones, and other similar computing devices. Additionally, the system can include portable storage media, such as universal serial bus (USB) flash drives. For example, the USB flash drives may store operating systems and other applications. The USB flash drives may include input/output components, such as a wireless transmitter or USB connector that may be inserted into a USB port of another computing device.

The system 1000 includes a processor 1010, a memory 1020, a storage device 1030, and an input/output device 1040. Each of the components 1010, 1020, 1030, and 1040 are interconnected using a system bus 1050. The processor 1010 is capable of processing instructions for execution within the system 1000. The processor may be designed using any of a number of architectures. For example, the processor 1010 may be a CISC (Complex Instruction Set Computers) processor, a RISC (Reduced Instruction Set Computer) processor, or a MISC (Minimal Instruction Set Computer) processor.

In one embodiment, the processor 1010 is a single-threaded processor. In another embodiment, the processor 1010 is a multi-threaded processor. The processor 1010 is capable of processing instructions stored in the memory 1020 or on the storage device 130 to display graphical information for a user interface on the input/output device 1040.

The memory 1020 stores information within the system 1000. In one embodiment, the memory 1020 is a computer-readable medium. In one embodiment, the memory 1020 is a volatile memory unit. In another embodiment, the memory 1020 is a non-volatile memory unit.

The storage device 1030 is capable of providing mass storage for the system 1000. In one embodiment, the storage device 1030 is a computer-readable medium. In various different embodiments, the storage device 1030 may be a floppy disk device, a hard disk device, an optical disk device, or a tape device.

The input/output device 1040 provides input/output operations for the system 100. In one embodiment, the input/output device 1040 includes a keyboard and/or pointing device. In another embodiment, the input/output device 1040 includes a display unit for displaying graphical user interfaces.

The features described can be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. The apparatus may be implemented in a computer program product tangibly embodied in an information carrier, e.g., in a machine-readable storage device for execution by a programmable processor; and method steps can be performed by a programmable processor executing a program of instructions to perform functions of the described embodiments by operating on input data and generating output. The described features may be implemented advantageously in one or more computer programs that are executable on a programmable system including at least one programmable processor coupled to receive data and instructions from, and to transmit data and instructions to, a data storage system, at least one input device, and at least one output device. A computer program is a set of instructions that can be used, directly or indirectly, in a computer to perform a certain activity or bring about a certain result. A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment.

Suitable processors for the execution of a program of instructions include, by way of example, both general and special purpose microprocessors, and the sole processor or one of multiple processors of any kind of computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Generally, a computer will also include, or be operatively coupled to communicate with, one or more mass storage devices for storing data files; such devices include magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and optical disks. Storage devices suitable for tangibly embodying computer program instructions and data include all forms of non-volatile memory, including by way of example semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, ASICs (application-specific integrated circuits).

To provide for interaction with a user, the features may be implemented on a computer having a display device such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor for displaying information to the user and a keyboard and a pointing device such as a mouse or a trackball by which the user can provide input to the computer.

The features may be implemented in a computer system that includes a back-end component, such as a data server, or that includes a middleware component, such as an application server or an internet server, or that includes a front-end component, such as a client computer having a graphical user interface or an internet browser, or any combination of them. The components of the system can be connected by any form or medium of digital data communication such as a communication network. Examples of communication networks include a local area network (LAN), a wide area network (WAN), peer-to-peer networks (having ad-hoc or static members), grid computing infrastructures, and the internet.

The computer system may include clients and servers. A client and server are generally remote from each other and typically interact through a network, such as the described one. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

Although illustrative embodiments have been described herein with references to the accompanying drawings, it is to be understood that the present disclosure is not limited those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the spirit or scope of the disclosure as defined by the appended claims. 

What is claimed is:
 1. A system for remote data gathering, monitoring, baseline staging, and treatment of Parkinson's disease comprising one or more remote interfaces being operatively connected to a remote data center via a data transmission means.
 2. The system of claim 1 wherein the one or more remote interfaces provide a portal to an application server at the remote data center.
 3. The system of claim 1 wherein the one or more remote interfaces is selected from the group consisting of: a patient interface, a healthcare provider interface, a physician interface, a researcher interface, an insurer interface, and a combination thereof.
 4. The system of claim 1 wherein the data transmission means is selected from the group consisting of: an Internet connection, a wide area network, a local area network, a wireless network, a cellular telephone, a satellite, a personal area network, a telephone dial up interface, analog signals, digital signals, and a combination thereof.
 5. The system of claim 3 wherein the remote patient interface further comprises: a means for performing one or more suites of tests; and a means for transmitting the results of the suites of tests to the application server.
 6. The system of claim 3 wherein the physician remote interface further comprises: a means for adding and removing a patient from the system; a means for managing passwords and access privileges; a means for accessing data collected from the one or more suites of tests a means for generating reports based upon the data collected from the one or more suites of tests; and a means for constructing a specific suite of tests.
 7. The system of claim 3 wherein the healthcare provider remote interface further comprises: a means for limited access to a patient's data; and a means for administering the one or more suites of tests to one or more patients.
 8. The system of claim 3 wherein the researcher remote interface further comprises: a means for accessing data collected from the one or more suites of tests; a means for generating reports based upon the data collected from the one or more suites of tests; and a means for aggregating quantities of data from multiple patients based upon specific criteria.
 9. The system of claim 3 wherein the insurer remote interface further comprises: a means for sending and receiving billing information; a means for paying bills; and a means for processing insurance claims.
 10. The system of claim 1 wherein the remote data center further comprises: a means for authenticating users of the system; a means for maintaining user information via a web server; a means for administering the one or more suites of tests via the application server; a means for creating a database of results from the one or more suites of tests via a database server; and a means for generating reports based upon the data collected from the one or more suites of tests via the application server.
 11. The system of claim 10 wherein the web server further comprises: a means for uploading patient data to the remote data center.
 12. The system of claim 1, that further comprises at least one remotely located patient device, wherein the patient device comprises a touch input screen, wherein the patient device interfaces with a data collection modality, wherein the data collection modality is at least one of a video capture device, a kinematic orientation/motion tracker, an accelerometer, a gyroscope, an attitude sensor, a global positioning system, a temperature monitor, a blood pressure monitor, a biometric security device, an electrocardiography (EKG/ECG) sensor, or an electroencephalography (EEG) sensor, and a data center comprising one or more servers comprising a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for: receiving patient data from the patient device, wherein the received patient data comprises motion capture data comprising motor symptoms of Parkinson's disease; identifying a sequence of medically related tests for monitoring Parkinson's disease based at least on the data collection modality that interfaces with the patient device, wherein the sequence of medically related tests comprises a test from a Unified Parkinson's Disease Rating Scale; wherein the sequence of medically related tests comprises a task to test abstract thinking; transmitting to the patient device at least one of the sequence of medically related tests for monitoring Parkinson's disease; and analyzing results of the at least one of the sequence of medically related tests to generate a baseline measurement that can be used to longitudinally track changes in Parkinson's disease.
 13. The system of claim 1, wherein the computer program logic further comprises instructions for administering the at least one of the sequence of medically related tests to a patient, wherein the results of the at least one of the sequence of medically related tests administered to the patient is received from the patient device to track a progression of Parkinson's disease; and
 14. optionally determining whether any additional tests should be transmitted to the patient device.
 15. The system of claim 1, wherein the data center further comprises a web server comprising a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for maintaining profiles and information of users of the system, wherein users of the system comprise at least one of a patient, a healthcare provider, a physician, a researcher, a fiduciary, or an insurer.
 16. The system of claim 1, wherein the data center further comprises: a database server comprising a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for storing a database of results from an administered sequence of medically related tests.
 17. The system of claim 1, wherein the data center further comprises an application server comprising a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for transmitting the sequence of medically related tests to the patient device.
 18. The system of claim 1, wherein the data center comprises a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for receiving the patient data in raw data format and processing the received raw data.
 19. The system of claim 1, wherein the data center comprises a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for receiving processed patient data.
 20. The system of claim 1, wherein the sequence of medically related tests comprises a cognitive test.
 21. The system of claim 1, wherein the data center comprises a non-transitory computer readable medium having computer program logic encoded thereon, wherein the computer program logic comprises instructions for communicating with the patient device, a healthcare provider device, a physician device, a researcher device, or an insurer device. 